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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K882484
Device Name CMS RECORD AND VERIFY SYSTEM
Applicant
Computerized Medical Systems, Inc.
56 Worthington Dr.
Maryland Heights,  MO  63043
Applicant Contact MELVIN MCCOLLUM
Correspondent
Computerized Medical Systems, Inc.
56 Worthington Dr.
Maryland Heights,  MO  63043
Correspondent Contact MELVIN MCCOLLUM
Regulation Number892.5900
Classification Product Code
JAD  
Date Received06/15/1988
Decision Date 12/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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